Prostate Cancer Clinical Trial
Official title:
Phase Ib Study of Monoclonal Antibody to OX40, Cyclophosphamide (CTX) and Radiation in Patients With Progressive Metastatic Prostate Cancer After Systemic Therapy
Verified date | August 2018 |
Source | Providence Health & Services |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This clinical trial will examine a novel combination of anti-OX40 to induce proliferation of memory and effector T cells in conjunction with cyclophosphamide (CTX) and radiation to induce tumor antigen release with the overall goal of promoting an immune response against prostate cancer.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 5, 2016 |
Est. primary completion date | July 5, 2016 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Patients with measurable or evaluable metastatic adenocarcinoma of the prostate. Either histologic or cytologic diagnosis is acceptable 2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 (Appendix A.) 3. Age 18 years old or above 4. Laboratory values (performed within 28 days prior to enrollment) as follows: - WBC = 2000/microlitre - Serum creatinine < 1.5 X upper limit of laboratory normal - Hgb > 8g/dl (patients may be transfused to reach this level) - Platelets > 100,000 cells/mm3 - Total bilirubin < 1.5 X upper limit of laboratory normal, unless due to Gilbert's disease - AST (SGOT) and ALT (SGPT) < 2.5 X upper limit of laboratory normal - Alkaline phosphatase < 2.5 X upper limit of laboratory normal (If alkaline phosphatase > 2.5 X upper limit of laboratory normal due to bone metastases, then patient is eligible.) - HIV 1 and 2 antibody Negative - Hepatitis B surface antigen Negative - Hepatitis C antibody Negative - PSA > 2 ng/ml - Testosterone < 50 ng/ml 5. Confirmed radiographic and/or PSA progression (using PCWG2 definitions) after at least one androgen ablation regimen and docetaxel.Patients who refuse docetaxel chemotherapy or who are not candidates for docetaxel are eligible to enroll. 6. At least one bone metastatic lesion amenable to radiation 7. Ability to give informed consent and comply with the protocol. Patients with a history of psychiatric illness must be judged able to understand the investigational nature of the study and the risks associated with the therapy 8. No active bleeding 9. No clinical coagulopathy (INR < 1.5, PT < 16 seconds, PTT < 38 seconds) 10. Anticipated lifespan greater than 12 weeks 11. Patients on LHRH agonists or bisphosphonates prior to study enrollment should continue these medications without change Exclusion Criteria: 1. Active infection. 2. Active autoimmune disease. 3. Previous treatment with mouse monoclonal antibodies 4. Need for chronic maintenance oral steroids. 5. Active brain metastatic disease. Patients with treated brain metastases with surgery, gamma-knife radiosurgery or radiation and stable for at least 4 weeks and off steroids are eligible. 6. Any medical or psychiatric condition that in the opinion of the PI would preclude compliance with study procedures. |
Country | Name | City | State |
---|---|---|---|
United States | Providence Portland Medical Center | Portland | Oregon |
Lead Sponsor | Collaborator |
---|---|
Providence Health & Services | MedImmune LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximum tolerated dose | The primary objective of this trial is to determine the maximum tolerated dose (within the range expected to induce anti-tumor and immunological effects) of CTX administered in combination with radiation and anti-OX40 in men with metastatic castrate- and chemotherapy-resistant prostate cancer. | The MTD will be assessed according to the dose escalation schema (timeframe is not specific for MTD assessment - it is based on enrollment)* | |
Secondary | Immune and Clinical Responses | Secondary objectives are as follows: Determine the effect of anti-OX40, CTX and radiation on circulating numbers and phenotypes of CD4 and CD8 T cells. Measure the proliferation and activity of effector and memory T cells after CTX, radiation and anti-OX40. Perform exploratory studies of cellular and humoral immune responses against prostate cancer cell lines. Estimate the response rate of the regimen that includes the highest dose of CTX determined to be safe. |
Days 11, 18, 25 and 39 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05540392 -
An Acupuncture Study for Prostate Cancer Survivors With Urinary Issues
|
Phase 1/Phase 2 | |
Recruiting |
NCT05613023 -
A Trial of 5 Fraction Prostate SBRT Versus 5 Fraction Prostate and Pelvic Nodal SBRT
|
Phase 3 | |
Recruiting |
NCT05156424 -
A Comparison of Aerobic and Resistance Exercise to Counteract Treatment Side Effects in Men With Prostate Cancer
|
Phase 1/Phase 2 | |
Completed |
NCT03177759 -
Living With Prostate Cancer (LPC)
|
||
Completed |
NCT01331083 -
A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05540782 -
A Study of Cognitive Health in Survivors of Prostate Cancer
|
||
Active, not recruiting |
NCT04742361 -
Efficacy of [18F]PSMA-1007 PET/CT in Patients With Biochemial Recurrent Prostate Cancer
|
Phase 3 | |
Completed |
NCT04400656 -
PROState Pathway Embedded Comparative Trial
|
||
Completed |
NCT02282644 -
Individual Phenotype Analysis in Patients With Castration-Resistant Prostate Cancer With CellSearch® and Flow Cytometry
|
N/A | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A | |
Recruiting |
NCT06305832 -
Salvage Radiotherapy Combined With Androgen Deprivation Therapy (ADT) With or Without Rezvilutamide in the Treatment of Biochemical Recurrence After Radical Prostatectomy for Prostate Cancer
|
Phase 2 | |
Recruiting |
NCT05761093 -
Patient and Physician Benefit/ Risk Preferences for Treatment of mPC in Hong Kong: a Discrete Choice Experiment
|
||
Completed |
NCT04838626 -
Study of Diagnostic Performance of [18F]CTT1057 for PSMA-positive Tumors Detection
|
Phase 2/Phase 3 | |
Recruiting |
NCT03101176 -
Multiparametric Ultrasound Imaging in Prostate Cancer
|
N/A | |
Completed |
NCT03290417 -
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
|
N/A | |
Completed |
NCT00341939 -
Retrospective Analysis of a Drug-Metabolizing Genotype in Cancer Patients and Correlation With Pharmacokinetic and Pharmacodynamics Data
|
||
Completed |
NCT01497925 -
Ph 1 Trial of ADI-PEG 20 Plus Docetaxel in Solid Tumors With Emphasis on Prostate Cancer and Non-Small Cell Lung Cancer
|
Phase 1 | |
Recruiting |
NCT03679819 -
Single-center Trial for the Validation of High-resolution Transrectal Ultrasound (Exact Imaging Scanner ExactVu) for the Detection of Prostate Cancer
|
||
Completed |
NCT03554317 -
COMbination of Bipolar Androgen Therapy and Nivolumab
|
Phase 2 | |
Completed |
NCT03271502 -
Effect of Anesthesia on Optic Nerve Sheath Diameter in Patients Undergoing Robot-assisted Laparoscopic Prostatectomy
|
N/A |